The study showed no clinically relevant difference in the pharmacokinetics, electrocardiogram (ECG) parameters or safety profile of BARHEMSYS between individuals with or without severe renal impairment. No adverse events were recorded in any subject.
The clinical trial was required by the
'We are pleased to have completed this study in a timely fashion, despite the challenges associated with running clinical trials during the COVID-19 pandemic, and are delighted with the uniformly positive results,' commented Dr.
About PONV
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys, even worse than pain.1
About BARHEMSYS
BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, which Acacia Pharma has developed and protected for the management of PONV.
Contact:
Tel: +44 1223 919760
Email: IR@acaciapharma.com
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.
Barhemsys (amisulpride) injection is a selective dopamine (D2 and D3) receptor antagonist approved and available in the US for the treatment and prevention of postoperative nausea & vomiting (PONV) in adult patients.
Byfavo (remimazolam) for injection, is an IV benzodiazepine sedative approved and available in the US for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Byfavo is in-licensed from
APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma has its US headquarters in
Forward looking statement
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'believe', 'expect', 'intend', 'may', 'plan', 'will', 'should', 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.
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